Infusion set

ABSTRACT

A single package infusion set is provided, including one or more of the following inserters: pushbutton-type, squeeze-type, contact-type, skin pinching-type, folding retraction-type, or multistage-type inserter having at least one reusable stage. The infusion set further includes adhesion means with user-selectable degrees of adhesion strength, self-sealing tube connection means, a lens feature to view, a site beneath the set, exemplary tube management and connection elements, insulin supply, adhesion concealment means, finger loops on the inserter and site preparation wipes or sprays, optionally provided as part of the inserter. The system further includes a package which may hold a number of easily released sets, retrievable by an inserter, an exemplary insertion needle handle and shroud, an exemplary squeeze-type latch between an upper portion and a lower portion of the set, and/or a tool removable upper portion of the set.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. § 119(a) of U.S.Provisional Application No. 61/202,019, entitled “Infusion Set”, filedon Jan. 21, 2009, the entire content, disclosure and subject matter ofsaid application being expressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to components, elements andpackaging of infusion sets, including features and elements in the areasof tube management, site management, set adhesion, set insertion, setplacement and changing operations and packaging.

BACKGROUND OF THE INVENTION

A large number of people, such as those suffering from conditions suchas diabetes use some form of infusion therapy, such as daily insulininfusions to maintain close control of their glucose levels. Currently,in the insulin infusion treatment example, there are two principal modesof daily insulin therapy. The first mode includes syringes and insulinpens. These devices are simple to use and are relatively low in cost,but they require a needle stick at each injection, typically three tofour times per day. The second mode includes infusion pump therapy,which entails the purchase of an insulin pump that lasts for about threeyears. The initial cost of the pump can be significant, but from a userperspective, the overwhelming majority of patients who have used pumpsprefer to remain with pumps for the rest of their lives. This is becauseinfusion pumps, although more complex than syringes and pens, offer theadvantages of continuous infusion of insulin, precision dosing andprogrammable delivery schedules. This results in closer blood glucosecontrol and an improved feeling of wellness.

As patients on oral agents eventually move to insulin and their interestin intensive therapy increases, users typically look to these insulinpumps for improvements in the management of their condition. Thereforeinterest in better pump-related therapy is on the rise. In this andsimilar examples, what is needed to fully meet this increased interestare advanced, improved, and novel new components, elements and packagingof current and future insulin infusion sets, including features andelements in the areas of tube management, site management, set adhesion,set insertion, set placement and changing operations and packaging.

Accordingly, a need exists for such advanced, improved, and novel newcomponents, elements and packaging of current and future infusion sets,that further provide simplicity in manufacture and use improvements forboth insulin and non-insulin applications.

SUMMARY OF THE INVENTION

An object of the present invention is to substantially address the aboveand other concerns, and provide advanced, improved, and novel newcomponents, elements and packaging of current and future infusion sets,that further provide simplicity in manufacture and use improvements forboth insulin and non-insulin applications.

Another object of the present invention is to provide a collection ofadvanced, improved, and novel new components and elements in a singlepackage to simplify assembly and use of the infusion set by the user.

Another object of the present invention is to provide an exemplarypushbutton-type inserter, squeeze-type inserter, contact-type inserter,skin pinching-type inserter, folding retraction-type inserter, and/ormultistage-type inserter having at least one reusable stage, which canbe provided in the single package to simplify assembly and use of theinfusion set by the user.

Another object of the present invention is to provide an exemplaryadhesion means with two or more user-selectable degrees of adhesionstrength which can be provided in the single package to simplifyassembly and use of the infusion set by the user.

Another object of the present invention is to provide an exemplaryself-sealing tube connection means which can be provided in the singlepackage to simplify assembly and use of the infusion set by the user.

Another object of the present invention is to provide an exemplary sethaving one or more clear and/or magnifying lens features to view a sitebeneath the set which can be provided in the single package to simplifyassembly and use of the infusion set by the user.

Another object of the present invention is to provide an exemplary tubemanagement element having a spring-loaded circular tube reel, tubingpull ties, elastic accordion, pouch or shortened length to manage a tubeor tube loop, which can be provided in the single package to simplifyassembly and use of the infusion set by the user.

Another object of the present invention is to provide an exemplary tubeconnection element including a tapered connector, detent connectorand/or a magnetic attraction connector, which can be provided in thesingle package to simplify assembly and use of the infusion set by theuser.

Another object of the present invention is to provide an exemplaryadhesion concealment means for concealment of the set once in positionand/or a decoration means for decoration of the set once in position,which can be provided in the single package to simplify assembly and useof the infusion set by the user.

Another object of the present invention is to provide an exemplary setplacement guidance ring and/or one or more finger loops on the inserterto aid in set placement, which can be provided in the single package tosimplify assembly and use of the infusion set by the user.

Another object of the present invention is to provide an exemplary sitepreparation wipe or spray which can be provided as part of the inserter,or otherwise included in the single package to simplify assembly and useof the infusion set by the user.

Another object of the present invention is to provide an exemplarypackage which can hold a number of sets that can be easily released andretrieved from the tray by an inserter to simplify assembly and use ofthe infusion set by the user.

Another object of the present invention is to provide an exemplaryinsertion needle handle and shroud which can be provided in the singlepackage to simplify assembly and use of the infusion set by the user.

Another object of the present invention is to provide an exemplarysqueeze-type latch between an upper portion and a lower portion of theset, and/or a tool removable upper portion of the set, which can beprovided in the single package to simplify assembly and use of theinfusion set by the user.

Another object of the present invention is to provide an annular fluidreservoir and/or fluid path in the set hub, which can significantlyminimize the penetration distance of the tubeset connector into the hubwhile maintaining a sufficiently large tubeset connector geometry.

Another object of the present invention is to provide substantiallyclosed or sealed annular fluid reservoir and/or fluid path in the sethub, which can reseal any insertion openings generated by the insertionneedle, and allow penetration by a tubeset connector needle.

Another object of the present invention is to provide an infusion setconstructed of a soft, pliable and/or elastic or similar material suchthat the infusion set is soft or pliable to a degree that allows theelasticity of the materials to affix a tube “ring” of the tubesetconnector to the hub.

Another object of the present invention is to provide an infusion setconstructed such that the tube ring of the tubeset connector can includethe tubeset connector needle to pierce the hub, wherein the elasticityof the materials function to seal the insertion site of the tubesetconnector needle.

Another object of the present invention is to provide an infusion setconstructed such that the tubeset connector needle of the tube ring ofthe tubeset connector can pierce the hub at any rotational position, andwherein the elasticity of the materials function to seal the insertionsite of the tubeset connector needle such that the tubeset connectorneedle of the tube ring of the tubeset connector can be withdrawn andthe tube ring repositioned at a different rotational alignment position.

Another object of the present invention is to provide a catheterconstructed of a body temperature softening polyurethane or similarmaterial, and include one or more features including a splined lumen andholes or openings along a body length, including cross-drilled holes.

These and other objects are substantially achieved by providing acollection of advanced, improved, and novel new components and elementsin a single package to simplify assembly and use of the infusion set bythe user, including one or more of an exemplary pushbutton-typeinserter, squeeze-type inserter, contact-type inserter, skinpinching-type inserter, folding retraction-type inserter, and/ormultistage-type inserter having at least one reusable stage. One or moreof the exemplary embodiments comprise a user gripping surface and ameans to release a firing spring for set placement, and one or moreretraction features to retract the insertion needle to avoid any dangersto the user and permit safe disposal. Further, one or more of theexemplary embodiments can comprise a set placement guidance ring to beplaced on the insertion site and which mates with an end of the inserterto ensure that the inserter is properly positioned before release of theset. Further, one or more of the exemplary embodiments can comprise oneor more finger loops extending from a body of the inserter to aid in setplacement. Still further, one or more of the exemplary embodiments cancomprise a squeeze-type latch between an upper portion and a lowerportion of the set comprising one or more pushbuttons which articulate alatch between the upper and lower portions, thereby releasing the upperportion of the set from the lower portion which can remain in position.In yet other embodiments of the present invention, the upper portion canbe configured to be tool-removable, such that the tool comprises one ormore pins which are inserted into the lower portion and release a latchbetween the upper and lower portions, thereby releasing the upperportion of the set from the lower portion which can remain in position.Still further, one or more of the exemplary embodiments can comprise aninsertion needle handle and shroud comprising one or more hinged flatmembers which can be bent to cover the protruding needle after use.

These and other objects are also substantially achieved by providing acollection of advanced, improved, and novel new components and elementsin a single package to simplify assembly and use of the infusion set bythe user, including one or more of an exemplary adhesion means with twoor more user-selectable degrees of adhesion strength comprising at leasea first and second adhesion ring having different degrees of adhesivestrength. The user can select which ring to use by removing a cover ofthe desired ring and leaving the remaining rings covered. A self-sealingtube connection means can be provided and comprise a set having a grooveinto which an elastic ring and tube connector can be positioned, suchthat the elastic ring secures the tube to the set and seals theconnection between each. The set can comprise one or more clear and/ormagnifying plastic components to view a site beneath the set, whereinthe adhesive pad is provided with one or more clearances to allow thevisual access.

These and other objects are also substantially achieved by providing acollection of advanced, improved, and novel new components and elementsin a single package to simplify assembly and use of the infusion set bythe user, including one or more tube management elements comprising aspring-loaded circular tube reel which serves to feed and retract excesstube as urged by a reel spring, one or more tubing pull ties which canbe pulled to either secure or release tubing being stored in a largeloop, an elastic accordion or pouch in which to store tubing, or provideshortened tube lengths between set and pump. Such tubing can furthercomprise one or more embodiments of a tube connection including atapered connector in which a tight engagement provides connection, adetent connector in which projecting detents and recessed detentsprovide connection, and a magnetic connector in which magneticattraction provides connection. Still further, an insulin supplycomprising an insulin content, supply vial and tubing can be providedwith the tubing and tubing connectors.

These and other objects are also substantially achieved by providing acollection of advanced, improved, and novel new components and elementsin a single package to simplify assembly and use of the infusion set bythe user, including one or more of an adhesion concealment means forconcealment of the set once in position comprising an adhesive pad to beplaced over a set to conceal the set, or a decorative adhesive pad to beplaced over a set to enhance the set. A site preparation wipe comprisinga disposable pad including a site preparation solution can be providedas well as an improved inserter body that comprises a spray mechanismand site preparation solution contents.

These and other objects are also substantially achieved by providing acollection of advanced, improved, and novel new components and elementsin an exemplary package comprising a number of openings into which setscan be aligned and secured by a covering, such as foil, and which allowsset removal by an inserter configured to pierce the foil and capture andremove the set from the tray.

BRIEF DESCRIPTION OF THE DRAWINGS

The various objects, advantages and novel features of the preferredembodiments of the present invention will be more readily appreciatedfrom the following detailed description when read in conjunction withthe appended drawings, in which:

FIGS. 1 and 2 are perspective views of a collection of infusion setelements and associated packaging in accordance with an exemplaryembodiment of the present invention;

FIGS. 3a-3e are cross-sectional views of an exemplary single-buttoninsertion device in accordance with an exemplary embodiment of thepresent invention;

FIGS. 4a-4c are perspective views of exemplary set adhesion elements inaccordance with an exemplary embodiment of the present invention;

FIGS. 5a-5d are views of an exemplary set connection method inaccordance with an exemplary embodiment of the present invention;

FIGS. 6a-6b are views of an exemplary set site inspection element inaccordance with an exemplary embodiment of the present invention;

FIGS. 7a-7b are views of an exemplary set tubing management element inaccordance with an exemplary embodiment of the present invention;

FIG. 8 is a perspective view of an alternate insulin supply andassociated tubing in accordance with an exemplary embodiment of thepresent invention;

FIGS. 9a-9b are perspective views of an exemplary set concealmentelement in accordance with an exemplary embodiment of the presentinvention;

FIGS. 10a-10c are perspective views of exemplary set placement elementsin accordance with an exemplary embodiment of the present invention;

FIG. 11 is a perspective view of an exemplary set site placementpreparation element in accordance with an exemplary embodiment of thepresent invention;

FIGS. 12a-12f are views of exemplary sets on tray packaging inaccordance with an exemplary embodiment of the present invention;

FIGS. 13a-13f are views of an exemplary multistage insertion device inaccordance with an exemplary embodiment of the present invention;

FIGS. 14a-14d are cross-sectional views of an exemplary “squeeze-type”inserter in accordance with an exemplary embodiment of the presentinvention;

FIGS. 15a-15e are views of an exemplary “contact-type” inserter inaccordance with an exemplary embodiment of the present invention;

FIGS. 16a-16c are views of an exemplary needle handle and shroud inaccordance with an exemplary embodiment of the present invention;

FIGS. 17a-17d are views of an exemplary “skin pinch-type” inserter inaccordance with an exemplary embodiment of the present invention;

FIGS. 18a-18e are views of an exemplary “folding/retracting-type”inserter in accordance with an exemplary embodiment of the presentinvention;

FIGS. 19a-19c are views of an exemplary “squeeze-type” latch provided asa connection method in accordance with an exemplary embodiment of thepresent invention;

FIGS. 20a-20d are views of an exemplary “tool-type” latch provided as aconnection method in accordance with an exemplary embodiment of thepresent invention;

FIGS. 21a-21c are perspective views of an exemplary pull tie, tubingmanagement element in accordance with an exemplary embodiment of thepresent invention;

FIGS. 22a-22c are perspective views of exemplary tubing connectingelements in accordance with an exemplary embodiment of the presentinvention;

FIGS. 23a-23b are perspective views of an exemplary elastic accordion,tubing management element in accordance with an exemplary embodiment ofthe present invention;

FIGS. 24a-24c are perspective views of an exemplary short tube, tubingmanagement element in accordance with an exemplary embodiment of thepresent invention;

FIGS. 25a-25b are perspective views of exemplary pouch-type, tubingmanagement elements in accordance with an exemplary embodiment of thepresent invention;

FIGS. 26a-26c are perspective views of exemplary decorative, functionalcovering elements in accordance with an exemplary embodiment of thepresent invention;

FIGS. 27a-27b are perspective views of an exemplary two-finger,placement element in accordance with an exemplary embodiment of thepresent invention;

FIG. 28 is a perspective view of an exemplary insertion tool-mountedspray, site preparation element in accordance with an exemplaryembodiment of the present invention;

FIG. 29a-29c are views of an exemplary hub including an annular fluidreservoir and/or fluid path for use with one or more exemplaryembodiments of the present invention; and

FIG. 30 is a cross-sectional view of a catheter including one or morecross-drilled holes and a splined lumen in accordance with an exemplaryembodiment of the present invention.

Throughout the drawings, like reference numerals will be understood torefer to like parts, components and structures.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

The embodiments of the present device described below illustrate anumber of advanced, improved, and novel new components, elements andpackaging of current and future infusion sets, that further providesimplicity in manufacture and use improvements for both insulin andnon-insulin applications. Exemplary embodiments are presented inseparate descriptions, although the individual features of theseembodiments can be combined in any number of ways to meet the needs ofthe user.

As will be appreciated by one skilled in the art, there are numerousways of carrying out the examples, improvements and arrangements ofinsulin-associated devices disclosed herein. Although reference will bemade to the embodiments depicted in the drawings and the followingdescriptions, the embodiments disclosed herein are not meant to beexhaustive of the various alternative designs and embodiments that areencompassed by the disclosed invention.

The embodiments of the present device described below illustrate anumber of features and elements in the areas of tube management, sitemanagement, set adhesion, set insertion, set placement and changingoperations and packaging. A collection of exemplary embodiments of thepresent invention is shown by way of example in FIGS. 1 and 2, whichserve to introduce elements described in greater detail below. FIG. 1illustrates an exemplary infusion set 10 including the followingfeatures. As shown in FIG. 1, an exemplary infusion set can comprise aninserter, such as the squeeze-type inserter 700 for use with a set, suchas the ring-sealed set 350. A tube and associated tube managementdevices, such as the circular reel 450, can be provided forcommunication with an insulin pump (not shown) or with an insulinsupply, such as the insulin supply 475. A placement assistance elementcan be provided, such as the placement assistance ring 526, and theentire arrangement can be placed into a sealed tray 12 with a number ofsite preparation elements, such as the pads 550, and site concealmentelements, such as the pads 500. The tray can be comprised of anysuitable plastic, fiber or composite material compatible with thecomponents, and can provide compartments, padding or element securingdetents or moldings. The set can be packaged in the tray 12 and sealedwith a clear and/or labeled cover 14, and includes every componentneeded to position, connect, insert, and wear the set, as well as theinsulin 475 itself as shown in FIG. 2. Each of the exemplary components,including a number of additional or alternate components, will now bedescribed individually in greater detail.

An exemplary embodiment of the present invention can be provided with aninsertion device as desired by a user. An exemplary insertion device 100is shown in FIGS. 3a-3e . The exemplary insertion device of FIGS. 3a-3eprovides an insertion device which can contain the set at an open,patient-contacting end, and provide an actuation button at an oppositeend. Upon activation, the insertion device places the set andautomatically retracts the insertion needle back into the insertiondevice.

As shown in FIG. 3a , the insertion device can comprise a substantiallycylindrical housing 102 from which a spring biased projection orpushbutton 104 can extend, and in which a set 106 can be positioned foruse. The housing 102 can have a first diameter at a lower portionthereof in which the set 106 can be positioned, and transition to areduced second diameter at an opposite end to substantially equal adiameter of the pushbutton 104.

Within the body of the housing 102, a number of elements are containedwhich serve to fire the set 106 into position, and then retract theinsertion needle. To do so, the housing 102 comprises a first, secondand third chamber 108, 110 and 112 of different widths. The firstchamber 108 at an uppermost portion of the housing 102 has a widthsufficient to slidably receive an end of an inserter rod 114. At anupper end of the first chamber 108, an opening is provided though whichthe pushbutton 104 slidably enters the first chamber 108, and a lowerend of the first chamber opens to create the second chamber 110 asdescribed in greater detail below. The first chamber further comprisesat least one inclined detent 116 disposed upon an inner wall of thefirst chamber 108 which serves to capture and secure a similar,deflectable detent 118 at an upper end of the inserter rod 114. One ormore further similar, deflectable detents 120 are disposed upon an end122 of the pushbutton 104 within the first chamber 108. The end 122 ofthe pushbutton 104 is provided to have a width substantially equal tothe width of the first chamber 108 to align and guide the pushbutton 104during operation. A spring 124 is disposed concentrically with thepushbutton 104 and is captured between an outer surface of the housing102 and an expanded head of the pushbutton 104 to constantly urge thepushbutton 104 upward.

As noted above, the pushbutton 104 comprises an end 122 with one or moreinclined detents 120. When pressed downward, the inclined detents 120come into contact with the inclined detents 118 of the inserter rod 114which are being held by the detents 116 of the first chamber 108. Thecontact releases the detents 118 and allows the inserter rod 114 to beurged downward by a firing spring 126 disposed within the second chamber110 of the housing 102.

The second chamber 110 has a width wider than that of the first chamber108, which is sufficient to slidably receive the inserter rod 114 andmore specifically, a width sufficient to slidably contain planar members128 and 132 of the inserter rod 114. The firing spring 126 is disposedconcentrically with the inserter rod 114 about an outer circumference ofthe inserter rod body as captured within the second chamber 110. Thatis, the firing spring 126 is captured within the second chamber 110 ofthe housing 102 between an upper wall of the second chamber 110, and theupper surface of the planar member 128 of the inserter rod 114. In doingso, the firing spring 126 constantly urges the inserter rod 114downward.

At a lower portion of the housing 102, the third chamber 112 can beprovided having a width wider than that of the second chamber 110,thereby creating a shoulder 130 therebetween. As described in greaterdetail below, the shoulder 130 is configured to allow downward travel ofthe inserter rod 114 and capture one or more detents on an outer surfaceof the inserter rod 114 to prevent retraction of the inserter rod 114,yet permit full retraction of a needle carrier and inserter needle.

As noted above, the inserter rod 114 is configured to slidably travelthough each of the first, second and third chambers 108, 110, and 112,of the housing 102. The inserter rod 114 is substantially cylindricaland comprises a diameter at an upper portion substantially equal to thewidth of the first chamber 108 to be directed and guided by the firstchamber 108 during use. A lower portion of the inserter rod 114comprises the first and second planar members 128 and 132, whichcomprise a diameter substantially equal to the width of the secondchamber 110 to be directed and guided by the second chamber during use.

As noted above, the inserter rod 114 comprises the first and secondplanar members 128 and 132. The inserter rod 114 further comprises aninserter needle guide 144 and at least third and fourth elements 136 and138 extending between the first and second planar members 128 and 132. Aspring 140 is captured between the needle guide 144 and fourth element138, and passes through an opening in the third element 136, toconstantly urge both the third and fourth elements 136 and 138 outwardfrom a center axis of the insertion device, and against an inner wall ofthe second and third chambers 110 and 112. The fourth element 138comprises an inclined detent 142 which is urged against the inner wallof the second and third chambers 110 and 112. In doing so, as theinserter rod 114 is urged downward and the detent 142 passes theshoulder 130, the spring 140 urges the element 138 against the innerwall of the third chamber 112 such that the detent 142 is captured bythe shoulder 130 and prevents the retraction of the inserter rod 114 asshown in FIGS. 3c and 3d . The needle carrier and inserter needle arepermitted to retract as described in greater detail below.

The third element 136 comprises at least one projection 146 which isconfigured to capture a groove 154 in the needle carrier 148 slidablydisposed within an inner opening of the inserter rod 114. The needlecarrier 148 secures the inserter needle 134 at a lower end, such thatthe inserter needle extends through the needle guide 144 and though anopening in the planar member 132 of the inserter rod 114. The needlecarrier 148 further comprises the groove 154 which can be captured bythe projection 146. The remainder of the needle carrier 148 extendsthrough the planar member 128 and into the inner opening of the inserterrod 114 and terminates at a planar end 150. The planar end 150 of theneedle carrier 148 has a width substantially the same as the width ofthe inner opening of the inserter rod 114 to align and guide the needlecarrier 148 during retraction. A retraction spring 152 is capturedbetween the planar end 150 of the needle carrier 148 and the planarmember 128 of the inserter rod 114. In doing so, the retraction spring152 constantly urges the needle carrier 148 upward.

While in the pre-use position, a large portion of the second chamber 110remains open to the end of the device. In doing so, the set 106 can bepositioned on the extended needle 134, at an opposite side of the secondplanar member 132 of the inserter rod 114. The set 106 can be gentlyheld within the second chamber 110 through contact with the walls of thechamber, and/or through contact with the inserter needle 134. As notedelsewhere, the set 106 can include any number or configurations ofadhesive pads (not shown) and other connection features, which can beaccommodated by the insertion device 100.

As shown in FIGS. 3a-3e , the compression of the push button 104releases the inclined detents 118 of the inserter rod 114 as shown inFIG. 3a , permitting the firing spring 126 to drive the needle 134, set106, and adhesive pad into the region of the skin beneath the thirdchamber 112 of the device as shown in FIG. 3b , and also releases thespring 140 to lock the inserter rod 114 in the extended position asshown in FIG. 3c . That is, upon release, the inserter rod 114 is freeto travel downward as urged by the trapped spring 126. In doing so, theinserter rod 114, including its end 132 and needle 134 travel downwardthrough the third chamber 112, urging the set 106 downward with it. Ator before reaching the travel limit of the inserter rod 114, the set 106is positioned, retraction of the needle carrier 148 and needle 134occurs, and the device can be removed as shown in FIG. 3d , therebyleaving the set 106 at the desired insertion site as shown in FIG. 3 e.

To retract the needle carrier 148 and needle 134, no user action isrequired. As shown in FIGS. 3c-3d , the shoulder 130 serves to hold theinserter rod 114 in the down position. When the insertion is completedand the inserter rod 114 is captured in the down position by the outwardmovement of members 136 and 138, the movement simultaneously releasesthe needle carrier 148 and needle 134, and allows the needle carrier 148and needle 134 to retract upward as urged by the retraction spring 152as shown in FIGS. 3c and 3d . The needle carrier 148 and needle 134 areretracted until contacting an upper stop 156 disposed at an upper end ofthe inserter rod 114.

The insertion device 100 of FIGS. 3a-3e uses the single button press ofthe pushbutton 104 to release the firing mechanism, insert the set 106,and safely retract the needle 134 after insertion. The insertion device100 is packaged and stored with the firing mechanism in an upright andlocked position, with the firing spring 126 compressed as shown. Theinserter rod 114 has the flexible wedge-shaped tabs or latches 120 atthe top of it, which are locked into grooves or captured by the detents116 at the interior top of the inserter's body 102 as shown in FIG. 3 a.

Pressing the activation button 104 unlatches the firing tabs at the topof the unit as shown in FIG. 3b , and permits the firing spring 126 toextend toward its free length, propelling the needle carrier assembly148 of the inserter rod 114 downward as shown in FIG. 3c . Upon reachingthe wider region of the body interior shaft at the third chamber 112,the two spring-loaded locking halves or members 136 and 138 of theneedle carrier assembly 148 move outward and lock the firing mechanismin the down position as shown in FIG. 3d , and frees the central portionof the needle carrier assembly 148 to move upward as shown in FIG. 3e ,leaving the remainder of the inserter rod 114 in the down position.

By this time, the needle 134 has pierced the skin and placed the cannulaand set 106, adhering it to the skin. Having been decoupled from theinserter rod 114 which has been driven downward and locked, the needlecarrier assembly 148 is now free to rebound, propelled upward by theretraction spring 152 as shown in FIG. 3e . After retracting fullyupward, the needle 134 is stored permanently and inaccessibly inside theinsertion device housing 102, and the device is inert.

In this and other inserter embodiments described below, the inserterbody and elements can be constructed of any suitable and compatiblematerials such as plastic or metal. Springs can be provided as coilsprings made of plastic or metal, although embodiments of the presentinvention are not limited thereto, and other spring or biasing means canbe used, such as leaf spring or simply material resiliency. Theinsertion needle can comprise any suitable set insertion needle of metalor plastic, having length, thickness, and bevel dimensions suitable forset insertion.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to manage the degree of adhesion of the device in some manneras desired by a user. As shown by way of example, adhesion managementelements 300 are shown in FIGS. 4a-4c . As shown in FIGS. 4a-4c , a set314 and catheter 316 are shown encircled by concentric rings of adhesive302 and 306. In an exemplary embodiment of the present invention, onering can provide an adhesive with a higher degree of adhesion strength,and another ring can provide an adhesive with a lesser degree ofadhesion strength, thereby allowing a user to tailor the degree of setadhesion to the user's activity plans. Although only two concentricrings of varied adhesive are shown in FIGS. 4a-4c , in yet otherembodiments of the present invention, more rings can be provided, or therings may be provided in alternate, non-circular shapes (i.e., such asoval shapes). Further, in the exemplary embodiment shown in FIGS. 4a-4c, the inner ring 306 is provided with the adhesive with a higher degreeof adhesion strength and the outer ring 302 is provided with theadhesive with a lesser degree of adhesion strength, but embodiments ofthe present invention are not limited thereto. In yet other embodimentsof the present invention, the order can be reversed or additional ringsof adhesive provided.

As noted by those skilled in the art, a set typically requires a degreeof adhesion to maintain proper positioning of the device. Accordingly,the exemplary embodiments of the present invention provide a set thatcomprises an adhesive pad or patch on the underside with auser-configurable adhesion mechanism to adapt the set to the expectedenvironment in which it will be worn. As shown in FIG. 4a , the adhesivepad or patch can be provided in two or more, selectable strengths whichcan be variably exposed and utilized depending on the user's preference.A region of basic adhesive 302 having a removable cover 304 segmentedfrom other covers, can be used for everyday needs while the region ofextra-strong adhesive 306 remains covered by a similar segmented cover308 as shown in FIG. 4b . The region of extra-strong adhesive 306 can beexposed by the removal of the cover 308 if athletic activities might beexpected to stress the set adhesion as shown in FIG. 4c . To furthersimplify use, each cover 304 and 308 of each region can comprise a tab310 and 312, respectively, to aid in removal of each adhesive cover. Thecovers 304 and 308 can also be labeled, color-coded or textured to showthe adhesive strength thereunder.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to provide a simple but effective connection system as desiredby a user. As shown by way of example, such a connection method 350 isshown in FIGS. 5a -5 d.

In such an exemplary embodiment, a set 352, once placed, has a port 354that should be able to be easily connected and disconnected with atubing 358 leading to an insulin pump (not shown). To do, the set 352can comprise the “self-sealing” connection port 354 on the outer,circular perimeter of the set 352, within a circumferential groove 356on the body of the set 352 as shown in FIG. 5a . An incoming tube 358can comprise a fitting 360 at the end designed to securely fit into andseal with the port 354 on the set 352, using the assistance of aflexible, resilient ring 362 extending outward from it as shown in FIG.5 b.

Connection of the tube 358 to the set 352 can then be accomplished bystretching the ring 362 around the far side of the set 352 as guided bythe groove 356 to a first diameter to allow placement, then placing theconnection fitting 360 into the port 354 as shown, and allowing theelastic ring 362 to contract to a second diameter to retain it securelyas shown in FIGS. 5c and 5d . The tube, set and connectors can beconstructed of any suitable material as described herein, and the ring362 can be constructed of any compatible, resilient material which canbe easily molded into the desired shape and maintain elasticity at leastfor an expected shelf life of the device. In a similar manner, theexemplary embodiment of the present invention shown in FIGS. 29a-29c ,described in greater detail below, comprises an infusion set constructedof a soft, pliable and/or elastic or similar material such that theinfusion set is soft or pliable to a degree that allows the elasticityof the materials to affix the tube ring of the tubeset connector to thehub in any number of rotational positions and which further includes atubeset connector needle to pierce the hub, wherein the elasticity ofthe materials function to seal the insertion site of the tubesetconnector needle.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to allow site inspection in some manner as desired by a user.As shown by way of example, a site inspection embodiment 400 is shown inFIGS. 6a-6b . As shown in FIGS. 6a-6b , a set 404 and its housing caninclude a means to inspect the region of the skin immediatelysurrounding the insertion point, to ensure that the site is in goodcondition. In an exemplary embodiment of the present invention, the set404 can include an element 402 extending from a top surface to a bottomsurface of the set 404 at some point near the insertion site. As shownin FIGS. 6a-6b , the element 402 completely encircles the site, butembodiments of the present invention are not limited thereto. In yetother embodiments of the present invention, the element 402 can beprovided over a narrower portion, but still sufficient to view the sitefrom above the device.

The element 402 can be constructed of any suitable material that can beeasily manufactured, bonded with the remaining elements of the set 404,provide compatibility with the contents or other materials, includingthe skin surface, and provide a degree of visibility between the top andbottom surfaces of the set 404. As shown in FIG. 6b , the sides of theelement 402 can be configured, contoured or otherwise provided withfeatures to be held in place by the body of the set 404, and a topsurface can be contoured to add a degree of magnification. For example,the housing of the set 404 or the top surface of the element 402 caninclude or comprise a clear plastic magnifying element that allows foreven better site inspection abilities.

Further, the element 402 can be provided with an upper surface opening412 to secure a septum 414 and for insertion of a placement needle 408into a catheter 410. The element 402 can further provide an opening 416to facilitate introduction of the infusion substance through the tubing406. Still further, where the lower surface of the set 404 is providedwith an adhesive pad (not shown) at the base of the set 404, theadhesive pad can include a cutaway portion to permit visibility throughthe element 402.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to secure, contain, and/or conceal the tubing of the device insome manner as desired by a user. As shown by way of example, a tubemanagement reel 450 is shown in FIGS. 7a-7b . The tubing 452 connectingthe insulin supply and pump (not shown) to the infusion set (not shown)can be packaged on a spring-loaded circular reel 454 disposed within orat one side of a reel housing 456.

As shown in the cross-sectional view of FIG. 7b , the tubing 452 canenter and exit the housing 456 at opposite sides near an upper surface,and wrap about a spring mechanism using pins 458. The construction of aspring-loaded circular reel is known to those skilled in the art, soadditional features of which are omitted for clarity. However, thecircular reel is provided with pins 458 between which the tube 452 issecured within the housing 456 such that, feeding tubing from thehousing results in the circular reel being wound tighter, and feedingtubing into the housing results in the circular reel being unwound andrelaxed. Accordingly, the circular reel and pins maintain a tension onthe tube 452 urging the tubing into the housing.

The circular reel can further comprise a catch/latch mechanism as knownto those skilled in the art such that pulling the tube 452 a first timefeeds a length of tube and a catch is provided to prevent a reversespring-urged action. Upon pulling the tube 452 a second time, the catchcan be released so that the reverse spring-urged action is released tourge the tube 452 back into the housing 456. In doing so, the reeldevice allows slack tubing to be fed out precisely, with springresistance maintaining the excess tubing rolled up and stored. Thelocking switch or latch can be provided to allow the user to preventinadvertent retraction or extension once a satisfactory length of tubinghas been deployed. The device can further comprise a switch 460 toactuate the tube retrieval.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to provide an insulin supply in some manner as desired by auser. As shown by way of example, an insulin supply 475 is shown in FIG.8. FIG. 8 illustrates an exemplary embodiment of an insulin container476 and associated tubing 478, including a tubing connection means 480.The insulin supply 476 can be packaged in a small, sealed or sealablecontainer that is pre-connected to a length of tubing 478. The insulincontainer 476 can be integrated with a pump mechanism (not shown)externally via an installation process which the user can easilyperform. The insulin container 476 and tubing 478, once connected to aset and pump, form a system that does not need to be primed for properfunction.

The insulin container 476 can be constructed of any suitable material,such as glass or plastic, to be clear to show the contents, or non-clearor opaque to protect contents from light. The container 476 can furtherinclude incremental dosage measurement marks along one or more surfacesfor use during content delivery. The associated tubing 478 andconnection means 480 can be constructed of any suitable material, suchas rubber, to provide flexibility and compatibility with the contents.The connection means 480 can be constructed in any number of ways, forexample, including the connection means described in greater detailbelow in regard to FIGS. 22a -22 c.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to provide set concealment in some manner as desired by a user.As shown by way of example, a concealment element 500 is shown in FIGS.9a-9b . In FIG. 9a , an adhesive covering 502, similar to a largeadhesive bandage, can be provided to enable the user to cover the site,including the set 504, with an inconspicuous dressing. In an exemplaryembodiment of the present invention, the covering 502 comprises aflexible, skin-colored adhesive covering that can have an adhesive sideand a non-adhesive side. The adhesive side can be covered with auser-removable cover (not shown) that when removed, allows the covering502 to be secured over the site, thereby covering and to a large degree,concealing the set 504 as shown in FIG. 9 b.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to aid and/or simplify placement of the device in some manneras desired by a user. As shown by way of example, a collection ofplacement assistance elements 525 is shown in FIGS. 10a-10c . Since theset and the corresponding insertion device can be unavoidably large indiameter and difficult to accurately locate in some circumstances, anexemplary kit including embodiments of the present invention can furtherinclude a placement ring to aid in placement of the set. An exemplaryplacement ring 526 is shown in FIG. 10a and can comprise a ring-shapedplastic part with one or more orienting features 530, such as keys, onits perimeter, and a self-adhesive, covered pad on the underside (notshown). A low-profile, contoured circular plastic ring is shown, butembodiments of the present invention are not limited thereto. As thering 526 can be provided with an adhesive pad, the ring 526 can be firstgently adhered to the skin surface with the target insertion site at thecenter as shown in FIG. 10b . This allows careful set placement as theinsertion site can now be better visualized though a center opening ofthe ring 526, and the insertion device 528, or tool, can be alignedwith, and guided into final position, by the placement ring 526.

The insertion device 528 can be provided for use with the placement ring526, and be constructed as described elsewhere herein and further havingcorresponding detents or keyways 532 to align with and receive theorienting features 530 of the placement ring 526. When the insertiondevice 528 is to be placed atop the placement ring 526 as shown in FIG.10c , the insertion device 528 self-aligns and orients for preciselocation of a set 534. In the exemplary embodiment shown, the orientingfeatures 530 are formed as raised contoured detents. Therefore, eachfurther serves to guide, center and align the insertion device 528 uponplacement. That is, such contoured elements provide a degree ofself-alignment not as readily provided by square elements for example.After insertion, the set 534 is left remaining at a center of the ring526 upon removal of the insertion device 528. The placement ring 526 canthen be removed and discarded.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional elements forthe use of site preparation. Such an exemplary feature is shown inelement 550 of FIG. 11. In the exemplary embodiment shown in FIG. 11,set packaging can further include a site preparation wipe 554 containedwithin a preservation container 552. The packaging for the set caninclude the wipe 554, such as a versatile disposable wipe, paper orcloth pad that is soaked or impregnated with one or more of adisinfectant, local anesthetic or other helpful substance. The pad orwipe 554 may also be constructed having a texture, coating, or othersurface feature 556 that can provide an exfoliating ability to aid inanesthetic effectiveness.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to provide a simple but effective means to provide packaging asa number of sets upon a tray as desired by a user. As shown by way ofexample, a “sets on tray” packaging arrangement 575 is shown in FIGS.12a-12f . As shown in FIGS. 12a-12f , a number of exemplary sets 576 canbe packaged upon a tray 578. Although the exemplary tray of FIG. 12ashows the containment of three sets, any number or arrangements of setscan be included as desired by the user.

As shown in FIG. 12a , a number of disposable sets or set components 576can be packaged in the exemplary multi-unit, foil or plastic-sealed tray578. In the exemplary embodiment of the present invention shown in FIG.12a , the tray 578 can be constructed of any suitable materialcompatible with the set and set components to be stored therein, and canprovide a number of recessed, contoured or otherwise constructedopenings 580 into which the sets or set elements 576 can be positioned.The openings 580 can be configured to securely hold and protect the setsprior to use, allow easy covering of the sets and tray surface with asealing means, such as foil or other material which can then be easilyremoved or punctured by the user to access the desired set and maintainprotection of remaining sets as shown in FIG. 12a , and which allowssuch access and removal using an inserter device 582 as shown in FIGS.12c -12 f.

As illustrated in the cross-sectional views of FIGS. 12c-12f , anexemplary insertion device 582 is shown having a contoured shape intowhich the set 576 can be captured. To do so, the insertion device 582can comprise one or mover deflectable ends 584 which can have aninclined latch 590 to pierce the tray covering 588 as shown in FIG. 12d, deflect outward slightly due to contact with the set 576, and thencapture an outer circumference of the set 576 once the latch 590 isfully inserted. In doing so, the insertion device 582 can be used toextract a new set 576 from the package so that the user will not need tocontend with opening and unsealing packaging materials. For example, anexemplary and reusable insertion device 582 for use which such a traycan comprise a hollow underside or lower surface, with the engagementfeatures of the latches 590 oriented inward towards the set 576, suchthat a user is simply required to align the insertion device 582 with aset, insert to a sufficient depth and retrieve the set 576 for use. Nofurther user action is required in regard to handling the set 576.

As shown in FIG. 12c , the sets 576 are aligned within each opening ofthe tray with sufficient clearance below the set to accommodate anyelements of the set. A substantial portion of the upper surface of theset can be exposed, wherein a foil or other covering 588 can be used tosecure the set 576 within the tray, and seal the contents of the trayand set 576 from contamination or other damage. In this exemplaryembodiment of the present invention, the foil 588 is shown covering thelimited space surrounding each device, but is not limited thereto. Inyet other embodiments of the present invention the foil or covering canbe more or less extensive upon the tray surface as desired.

As shown in FIG. 12d , the insertion device 582 can self-align on theblister-type package of the set 576 on the tray 578, and when presseddown, can cut through the foil or plastic seal 588 as shown in FIGS. 12cand 12d . As the insertion device 582 presses down further, it alsodisengages the set 576 from the packaging tray 578 with the perimeter ofthe inserter body. After pushing past the edge of the set 576, thelocking tabs or latches 590 on the insertion device 582 engage andsecure the outer circumference of the set 576, and allow the user toextract both the insertion device 582 and the set 576 from the tray 578as shown in FIG. 12f . The insertion device and the set are then readyto fire in normal use. The remaining sets of the tray are left intactand ready for later use. In exemplary embodiments of the presentinvention, the removal of the set 576 from the tray also results in theautomatic removal of any needle cover and adhesive backing, which isleft with the tray 578.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to provide a simple but effective multistage-type inserter asdesired by a user. As shown by way of example, a “multistage-type”inserter device 600 is shown in FIGS. 13a-13f . In such an exemplaryembodiment, the insertion device can be constructed in such a way as toseparate high-cost parts from low-cost parts, keeping the former in areusable mechanism while allowing the latter to be safely disposed.

As shown in FIG. 13a , the multistage-type inserter device 600 cancomprise a substantially cylindrical upper and lower element 602 and604, respectively. The upper element 602 can have a first diameter at alower portion thereof to seamlessly mate with the lower element 604. Anupper portion of the upper element 602 can have a second diameter whichis flared or expanded to provide sufficient room for operation of hingedlatches 606 as described in greater detail below. The lower element 604can also have a first diameter at an upper portion thereof to seamlesslymate with the upper element 602, and a second diameter at a lowerportion which is flared or expanded to contain a set 642.

The upper element 602 can comprise at least one firing mechanismconsisting of at lease one hinged latch 606 rotatable about a pin 608 orother means, and which has a inclined projection 610. Each projection610 includes an inclined lower surface to facilitate assembly with thelower element 604, and a substantially flat upper surface to restrictsome portion of an inserter rod 614 as described in greater detailbelow. The upper element 602 further comprises a first chamber 612 inwhich a firing spring 624 is captured. The upper element 602 andcontents thereof can comprise a reusable element that can be installedonto a disposable mechanism of the lower element 604 which can include aset, needle, adhesive pad, and a portion of the insertion mechanism.

The inserter rod 614 extends though both the upper and lower elements602 and 604, and comprises a cross-member 616, a shoulder 618 and aplanar end 620. The inserter rod 614 further comprises an inserterneedle 622, which can be secured within a center opening of the inserterrod 614, and can extend downward from the rod at the end 620. Both thecross-member 616 and the lower end 620 are configured to have a widthsubstantially equal to the width of the chamber in which each ispositioned to facilitate alignment and travel of the inserter rod 614during use. As described in greater detail below, the cross-member 616is configured to be held in an up position by the projections 610 of thelatches 606, and is configured to be blocked at a down position by theprojections 633 of the lower element 604. Further, the lower part of theshoulder 618 is configured to have a partially flat surface upon whichthe retraction spring 638 rests, and a partially inclined surface suchthat the shoulder can be easily forced through the opening of thepartition 634 by the firing spring 624. The upper part of the shoulder618 is configured to have a substantially flat surface to be captured bythe opening of the partition 634 and prevent upward travel of theinserter rod 614 for retraction until released.

The upper portion 602 comprises the first chamber 612 in which thefiring spring 624 is captured. The firing spring 624 is disposedconcentrically about the inserter rod 614 and is captured between anupper wall of the first chamber 612 and the cross-member 616 of theinserter rod 614. In doing so, the firing spring 624 is configured toconstantly urge the inserter rod 614 downward. Prior to use, theinserter rod 614 is held in an up position by one or more of theprojections 610 of the hinged latch 606. Specifically, an inner surfaceof the hinged latch 606 comprises one or more of the projections 610which extend a slight distance from the inner surface of the hingedlatch 606, and which block the travel of the cross-member 616 of theinserter rod 614. In such a position, the firing spring 624 iscompressed and the latches 606 capture the upper portion of the needleassembly as shown in FIG. 13b . The capture of the upper portion of theinserter rod 614 by the projections 610 of the latches 606, and theforce applied by the firing spring 624 while in the pre-use position,also serves to secure the upper housing 602 to the bottom housing 604prior to use. Once the latches 606 are released from the inserter rod614, the upper housing 602 is free of the lower housing 604 and can belifted away as shown in FIGS. 13c -13 d.

The upper housing 602 can further comprise an opening 642 which canserve to support the firing spring 624 in position, and serve to guidethe inserter rod 614 during use. The opening 642 can further reveal anextended portion of the inserter rod 614 as shown in FIG. 13b such thata user can confirm visually or by touch that the elements are allpresent and are properly assembled and ready for use.

The lower portion 604 comprises a second, third and fourth chamber 626,628 and 630. The second chamber 626 is substantially open at an uppersurface to slidably receive the inserter rod 614 as guided by thecross-member 616 as urged downward by the firing spring 624 whenreleased. The second chamber 626 comprises at least one projection 633which extends inward from an inner surface of the second chamber 626. Indoing so, the projection 633 provides a downward travel limit of theinserter rod 614 through the contact between the cross-member 616 andthe projection 633. As noted above, the width of the second chamber andthe cross-member 616 are configured such that the inserter rod 614 iscentered and guided by each.

The second and third chambers 626 and 628 are separated by a partition634 having an opening 640 through which the inserter rod 614 extends.The opening 640 of the partition 634 is configured to have an inclinedupper opening surface through which the inclined lower surface of theshoulder 618 can more easily pass as urged downward by the firing spring624. The lower surface of the opening 640 of the partition 634 isconfigured to be substantially flat such that the flat upper surface ofthe shoulder 618 cannot pass back though the partition 634 untilreleased for retraction as described in greater detail below. Further,the partition 634 comprises at least one segment extending some distancefrom an outer surface of the lower element 604 (i.e., an extended userlever) such that the partition 634 can be deflected by the user forretraction as described in greater detail below.

The third and fourth chambers are also separated by a partition 636,which also includes an opening through which the inserter rod 614extends. The third chamber 628 further comprises the retraction spring638. The retraction spring is positioned concentric with the inserterrod 614, and is captured within the third chamber 628 between thepartition 636 and the shoulder 618 of the inserter rod 614. In doing so,the retraction spring 638 is configured to constantly urge the inserterrod 614 upward.

Prior to use, the firing spring 624 in the upper portion 602 iscompressed and the retraction spring 638 in the lower portion 604 isrelaxed as shown in FIG. 13b . During use, the release of the firingspring 624 operates the inserter as described in greater detail below,and further serves to compress the retraction spring 638 as shown inFIG. 13c . After use, the inserter rod 614 is held in position by thecontact between the shoulder 618 and the partition 634 as shown in FIG.13d . To retract the inserter rod 614, the user than presses on theextended portions of the partition 634. As shown in FIGS. 13d and 13e ,the restrictive opening 640 of the partition 634 serves to hold theinserter rod 614 in the down position. When the insertion is completedand the upper portion 602 is removed, the user can press the extendedportions of the partition 634, and the opening 640 is enlarged andallows the shoulder 618 to retract upward as urged by the retractionspring 638 as shown in FIG. 13 e.

While in the pre-use position, a large portion of the lower portion 604remains open to the end of the device. In doing so, the set 642 can bepositioned on the extended needle 622, at an opposite side of the end620 of the inserter rod 614. The set 642 can be gently held within theportion 604 through contact with the walls of the portion, and/orthrough contact with the inserter needle 622. As noted elsewhere, theset can include any number or configurations of adhesive pads (notshown) and other connection features, which can be accommodated by thetwo-part inserter.

As shown in FIGS. 13a-13f , the compression of the latches 606 releasesthe projection latch on the needle assembly of the inserter rod 614,permitting the firing spring 624 to drive the needle 622, set 642, andadhesive pad into the region of the skin beneath the portion 604, andalso compress the retraction spring 638. That is, upon release, theinserter rod 614 is free to travel downward as urged by the trappedspring 624. In doing so, the inserter rod 614, including its end 620 andneedle 622 travel downward through the portion 604, urging the set 642downward with it. At or before reaching the travel limit of the inserterrod 614, the set is positioned, and the device can be removed as shownin FIG. 13f , thereby leaving the set 642 at the desired insertion site.

Then, to retract the inserter rod 614, including its end 620 and needle622, the user then presses on the extended portions of the partition634. As shown in FIGS. 13d and 13e , the restrictive opening 640 of thepartition 634 serves to hold the inserter rod 614 in the down position.When the insertion is completed and the upper portion 602 is removed,the user can press the extended portions of the partition 634, and theopening 640 is enlarged and allows the shoulder 618 to retract upward asurged by the retraction spring 638 as shown in FIG. 13e . The inserterrod 614 is prevented from completely exiting the lower portion 604 bythe contact between the lower end 620 and the partition 636.

As noted above, the exemplary embodiment of the present inventionillustrates an insertion device 600 that can be constructed in such away as to separate high-cost parts from low-cost parts, keeping theformer in a reusable mechanism while allowing the latter to be safelydisposed as shown in FIG. 13a . A firing mechanism consisting of thehinged latches 606 and an extended, large spring is installed onto adisposable mechanism which includes the set 642, the needle 622, theadhesive pad, and a portion of the insertion mechanism. As shown, thefiring spring 624 is compressed and the latches 606 capture the upperportion of the needle assembly or inserter rod 614 as shown in FIG. 13b. The device is now ready to be placed and fired.

Once the user squeezes the latches 606 on the upper part of the device,the needle assembly or inserter rod 614 becomes free to move, and isdriven downward by the firing spring 624, piercing the skin, insertingand adhering the set 642 as shown in FIG. 13c . The downward motion ofthe needle assembly or inserter rod 614 also drives two secondarylatches on the lower portion of the device outward to capture theinserter rod 614 within the opening 640 and compresses the return orretraction spring 638. After removal of the reusable part 602 of thedevice 600, the lower part of the device 604 remains in place and theneedle will still be inserted in the skin as shown in FIG. 13d . Toremove the needle 622, the latches or the member 634 can be deflected asshown in FIG. 13e to allow the return or retraction spring 638 toextract the needle 622 and render the lower part 604 of the assembly 600inert and disposable. The inserter rod 614 is prevented from completelyexiting the lower portion 604 by the contact between the lower end 620and the partition 636.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to provide a simple but effective “squeeze-type” inserter asdesired by a user. As shown by way of example, a “squeeze-type” inserterdevice 700 is shown in FIGS. 14a-14d . As shown in FIGS. 14a-14d , anexemplary embodiment of the present invention can be activated bypressing the device against the targeted portion of the skin and thensqueezing a portion of the inserter body.

An exemplary construction of the squeeze-type insertion device 700 cancomprise a body having at least three portions 702, 704 and 706. Theportions 702 and 706 can comprise rigid structures, having a flexibleuser-deflectable portion 704 disposed therebetween. The upper portion702 can comprise a substantially cylindrical outer surface having arounded and closed end, and an opposite end which seamlessly mates withthe outer surface of the user-deflectable portion 704. The lower portion706 can have a larger diameter, substantially cylindrical outer surface,with a contour configured to seamlessly mate with the outer surface ofthe user-deflectable portion 704. Accordingly, the user-deflectableportion 704 can have a substantially cylindrical outer surface having acontour to provide seamless mating with the outer surface of the upperand lower portions 702 and 706. The portions 702, 704 and 706 can beconstructed as a single element wherein each section is separated fromthe adjacent section by one or more cuts, which allow the segments tomaintain assembly, but allow for the deflection of the user-deflectableportion 704 as described in greater detail below. Further, an inserterrod 712 is slidably captured within the device 700 and extends througheach portion as guided by an inserter rod cross-member 714. The inserterrod 712 further comprises a lower planar end 722 and an inserter needle724, which can be secured within a center opening of the inserter rod708, and can extend downward from the inserter rod 712 at the end 722.Both the cross-member 714 and the lower end 722 are configured to have awidth substantially equal to the width of the chamber in which each ispositioned to facilitate alignment and travel of the inserter rod 712during use.

As shown in FIGS. 14a-14c , the upper portion 702 provides a firstchamber 708 in which a firing spring 710 is captured. Specifically, thefiring spring 710 is positioned concentric with the inserter rod 712,and is captured at one end by an upper wall of the first chamber 708,and at an opposite end by the inserter rod cross-member 714. In doingso, the firing spring 710 is configured to constantly urge the inserterrod 712 downward.

Prior to use, the inserter rod 712 is held in position by one or moreprojections 716. Specifically, an inner circumference of theuser-deflectable portion 704 comprises one or more of the projections716 which extend a slight distance from the inner circumference of theuser-deflectable portion 704, and which block the downward travel of thecross-member 714 of the inserter rod 712. The projections 716 areprovided at an uppermost point of the portion 704 as this pointundergoes the greatest degree of deflection during user deflection asdescribed in greater detail below. Accordingly, in such a position, thedegree of deflection of the projections 716 is maximized as shown inFIG. 14b to simplify the release of the inserter rod 712.

The user-deflectable portion 704 provides a second chamber 718 throughwhich the inserter rod 712 is positioned and which includes a travellimit element 720. Although any part of the user-deflectable portion 704can be compressed by a user, an exemplary embodiment of the presentinvention can provide one or more designations on an outer surface ofthe user-deflectable portion 704 to identify each as a preferred“squeeze button” area. Once the user-deflectable portion 704 iscompressed by the user as shown in FIG. 14b , the projections 716release the cross-member 714 of the inserter rod 712 and the firingspring 710 urges the inserter rod 712 downward through the secondchamber 718 until the cross-member 714 is restricted from furtherdownward travel by the travel limit element 720 as shown in FIG. 14c .As noted above, the portions 702, 704 and 706 can be constructed as asingle element wherein each section is separated from the adjacentsection by one or more cuts, which allow the segments to maintainassembly but allow for the deflection of the user-deflectable portion704. Accordingly, the engagement between the portions 704 and 708 can bedeflected in a manner similar to that of the deflection between theportions 702 and 704 described above in regard to the release of theinserter rod 712.

While in the pre-use position, a large portion of the lower portion 706remains open to the end of the device. In doing so, a set 726 can bepositioned on the extended needle 724, at an opposite side of the end722 of the inserter rod 712. The set 726 can be gently held within theportion 706 through contact with the walls of the portion, and/orthrough contact with the inserter needle 724. As noted elsewhere, theset 726 can include any number or configurations of adhesive pads (notshown) and other connection features, which can be accommodated by thesqueeze-type inserter.

As shown in FIGS. 14a-14d , the compression of the user-deflectableportion 704 releases the projection latch 716 on the needle assembly ofthe inserter rod 712, permitting the firing spring 710 to drive theneedle 724, set 726, and adhesive pad into the region of the skinbeneath the portion 706. That is, upon release, the inserter rod 712 isfree to travel downward as urged by the trapped spring 710. In doing so,the inserter rod 712, including its end 722 and needle 724 traveldownward through the portion 706, urging the set 726 downward with it.At or before reaching the travel limit of the inserter rod 712, the set726 is positioned, and the device 700 can be removed as shown in FIG.14d , thereby leaving the set 726 at the desired insertion site.

Such an exemplary embodiment of the present invention provides a moreconvenient means of actuating an insertion device by simply using“squeeze” buttons to initiate the process as shown in FIG. 14a . Asshown in FIG. 14b , buttons on the side of the device at theuser-deflectable portion 704 can be pressed inward, unlatching theneedle assembly or inserter rod 712 and permitting it to be propelleddownward by the firing spring 710 as shown in FIGS. 14b and 14c . Thespring-loaded needle delivers the set 726 and adhesive pad to the skin.The device 700 can then be removed as shown in FIG. 14d , therebyleaving the set 726 at the desired insertion site.

In contrast to the other inserter devices described herein, thematerials of the squeeze-type inserter 700 allow for the squeeze actionof the one or more portions, or the construction of one or more portionshaving thinner, thereby deflectable parts.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to provide a simple but effective skin contact-type inserter asdesired by a user. As shown by way of example, a “skin contact-type”inserter device 800 is shown in FIGS. 15a-15e . As shown in FIGS.15a-15e , an exemplary embodiment of the present invention is shownwherein the insertion device can be activated by pressing the device upagainst the targeted portion of the skin.

An exemplary construction of the insertion device 800 can comprise anupper and lower portion 802 and 804, respectively. The upper portion 802can be comprised of a dome-shaped element into which a slidably engagedlower portion 804 can be captured. Specifically, the upper portion 802can comprise a substantially round, dome-shaped element having aflattened portion at an uppermost point. The upper portion 802 canfurther comprise one or more deflectable tabs 806, or cut portions,about a body circumference as described in greater detail below. Theinner surface of the tabs 806 are provided with an incline 824 and aprojection 818 at the uppermost point of each incline.

Within the upper portion 802, exemplary embodiments of the presentinvention comprise an inserter rod 808 slidably disposed within theupper portion and which is held in place by the tabs 806. As shown inFIGS. 15b-15e , the inserter rod 808 comprises a planar end 814 whereina notch 816 is proved at each side of the planar end 814, which engagesthe projections 818 of the tabs 806 that extend into the upper portion802. Accordingly, prior to use, the projections 818 secure the notches816 of the planar end 814 of the inserter rod 808, preventing movementof the inserter rod 808. The inserter rod 808 further comprises aninserter needle 828, which can be secured within a center opening of theinserter rod 808, and can extend downward from the rod at the planar end814.

The upper portion 802 further comprises a firing spring 810 that isdisposed concentrically with the inserter rod 808 and which is capturedbetween the end 814 of the inserter rod 808 and one or more features ofthe upper flattened surface of the upper portion 802. In the exemplaryembodiment shown, the upper flattened surface of the upper portion 802can comprise a molding 820 having a cup-shaped opening 812 that is sizedto capture and hold an end of the firing spring 810. In this position,the firing spring 810 serves to constantly urge the inserter rod 808downward. However, as noted above, prior to use, the inserter rod 808 isheld in place by the tabs 806.

Accordingly, the device 800 further comprises the slidably engaged lowerportion 804 which is slidably captured at an end of the upper portion802 by one or more contacting tabs 822 of portion 804, and tabs 832 ofthe upper portion 802. The lower portion 804 has a diameter slightlyless than an inner diameter of the upper portion 802 such that the lowerportion 804 is gently held in place prior to use but upon contact with askin surface, can be easily slid upward into the upper portion 802. Indoing so, the tabs 822 of the lower portion 804 travel against an innercircumference of the upper portion 802, and onto the tabs 806.Specifically, the tabs 822 of the lower portion 804 travel against theincline 824 of the tabs 806, which forces the tabs 806 outward andreleases the projections 818 from the notches 816 of the planar end 814of the inserter rod 808 as shown in FIG. 15c . Once released in such amanner, the inserter rod 808 is free to travel downward as urged by thefiring spring 810.

While in the pre-use position, a large portion of both the upper andlower portions 802 and 804 remain open to the end of the device 800. Indoing so, a set 826 can be positioned on the extended needle 828, at anopposite side of the planar end 814 of the inserter rod 808. The set 826can be gently held within the upper portion 802 through contact with thewalls of the upper or lower portion, and/or through contact with theinserter needle 828. As noted elsewhere, the set 826 can include anynumber or configurations of adhesive pads (not shown) and otherconnection features, which can be accommodated by the skin contactinserter.

As shown in FIGS. 15b-15d , the slidable motion of the lower portion 804into the upper portion 802 releases the pin latch 818 on the needleassembly of the inserter rod 808, permitting the firing spring 810 todrive the needle 828, set 826, and adhesive pad into the region of theskin beneath the lower portion 804. That is, upon release, the inserterrod 808 is free to travel downward as urged by the trapped firing spring810. In doing so, the inserter rod 810, including its end 814 and needle828 travel downward through the lower portion 804, urging the set 826downward with it. At or before reaching the travel limit of the inserterrod 808, the set 826 is positioned, and the device 800 can be removed asshown in FIG. 15e , thereby leaving the set 826 at the desired insertionsite.

As described above, the lower portion 804 of the device becomes amovable actuation mechanism. In this case, a circumference or ringaround the lower perimeter of the lower portion 804 of the device,surrounding the set 826 and needle 828, is placed against the skinsurface (not shown). The entirety of the device 800 is then pressedfirmly downward. The lower ring of the lower portion 804 telescopes intothe main body of the upper portion 802 of the device and as it travelsinward/upward, it deflects the multiple latches around the perimeterprovided by the tabs 806, which permit the firing spring 810 to drivethe needle 828, set 826, and adhesive pad into the skin. The device 800can be removed as shown in FIG. 15e , thereby leaving the set 826 at thedesired insertion site.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to provide a needle handle and/or shroud in some manner asdesired by a user. As shown by way of example, a needle handle andshroud 900 is shown in FIGS. 16a-16c . In doing so, an enhancement canbe provided to current manually inserted needles for set insertion byimplementing a plastic handle 902 and a substantially circular andhinged shield 904 for use with the needle 906 and set (not shown). Thehandle 902 permits a sure grip on the needle 906 for insertion, whilethe circular shield 904, as shown, helps to firmly press the set and setadhesive into place as shown in FIG. 16a . After placement, when theneedle 906 is withdrawn, the hinged portions of the shield 904 can befolded down at each of hinges 908, as shown in FIG. 16b and thecross-sectional view of FIG. 16c , to allow for safer needle disposal.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to provide a simple but effective skin pinch-type inserter asdesired by a user. As shown by way of example, a “skin pinch-type”inserter device 925 is shown in FIGS. 17a-17d . As shown in FIGS.17a-17d , an exemplary set can be packaged with a skin pinch-typeinserter 925 with which a user can grasp a portion of the user's skin S(see, e.g., FIG. 17a ) to improve insertion of the set. The exemplaryinsertion device 925 can be integrated into a mechanism as described ingreater detail below that incorporates features to do this.

An exemplary construction of the insertion device 925 can comprise alarge clothespin-like clamp 926, having opposite sides or legs 928 whichrotate about a pin or other securing means 930. Such an exemplary clamp926 can further provide a space therein in which a number of remainingcomponents can be centered. The large clothespin-like clamp 926 caninclude the wide, manually-actuated legs 928 as shown in FIGS. 17a-17b .The legs 928 can be configured to be at slight angles while at rest suchthat a width between the legs 928 at the skin contact surface is widerthan a width between the legs 928 at opposite ends. When activated by auser, the user places the entire device 925 against the skin surfacesuch that the wider opening contacts the skin surface. The user thangrasps the legs 928 at a point near the skin surface and “pinches” thelegs 928 into a substantially parallel position, such that the legs 928extend vertically from the skin surface as shown in FIG. 17c . That is,the device can be placed on the skin surface, surrounding the targetarea, and the pinching legs 928 can be squeezed inwards. When pinched,the legs 928 in contact with the skin surface serve to prepare the skinsurface in a number of different ways for set placement, including, butnot limited to, stretching the skin at the site, leveling the skin atthe site and/or raising the skin at the site.

The squeezing of the legs 928 is also tied to a latching mechanism inthe central section of the device 925. That is, when a desired degree ofskin pinch is achieved, the device automatically begins the process ofreleasing and placing the set. To do so, the device 925 can furthercomprise a first and second chamber therein. The first chamber 932 issecured to the second chamber 934, which is secured at opposite cornersto an inner surface of the legs 928. The legs 928 further comprise atleast one articulated pin 936 which is inserted into the first chamber932 when the device is at rest as shown in FIG. 17b . The articulatedpin 936 can include one or more joints or segments along its length,such that there is no interference with the movement of the legs 928during operation.

The articulated pin 936 extends from an inner surface of the legs 928,through an opening in the side of the first chamber 932 and secures aplanar end 938 of an inserter rod 940. As shown in FIG. 17b , in doingso, the pin 936 holds the inserter rod 940 in an up and retractedposition. As the legs 928 are pinched, the articulated pin 936 is pulledclear of the planar end 938 which allows the inserter rod 940 to moveforward as urged by a firing spring 946.

As shown in FIGS. 17b-17c , the firing spring 946 is captured in thesecond chamber 934. Specifically, the first and second chambers are incommunication via an opening therebetween through which the inserter rod940 extends. The planar end 938 of the inserter rod 940 is captured inthe first chamber, and can be held at an upper and retracted position inthe first chamber by the articulated pin 936. The remainder of theinserter rod extends into the second chamber 934 and terminates at anopposite planar end 944, and further comprises an inserter needle 942.The inserter needle 942 can be secured within a center opening of theinserter rod 940, and can extend from the rod at the planar end 944 intothe second chamber 934. Both planar ends 938 and 944 are configured tohave a width substantially equal to the width of the chamber in whicheach is positioned to facilitate alignment and travel of the inserterrod 940 during use.

The firing spring 946 is placed concentrically about the inserter rod940 and is captured by the inserter rod 940 within the second chamber934, between the end 944 and an upper wall of the second chamber 934,and is configured to be in a compressed state prior to use, and uponrelease of the articulated pin 936, is further configured to urge theinserter rod 940 downward toward the insertion site. As shown in FIG.17b , while in the pre-use position, a large portion of the secondchamber 934 at an opposite side of the planar end 944 remains open tothe end of the device. In doing so, a set 948 can be positioned on theextended needle 942 within the second chamber 934, at an opposite sideof the planar end 944 of the inserter rod 940. The set 948 can be gentlyheld within the second chamber 934 through contact with the walls of thechamber, and/or through contact with the inserter needle 942. As notedelsewhere, the set 948 can include any number or configurations ofadhesive pads (not shown) and other connection features, which can beaccommodated by the skin pinch inserter.

As shown in FIGS. 17b-17c , the motion of the legs 928 releases the pin936 latch on the needle assembly of the inserter rod 940, permitting thefiring spring 946 to drive the needle 942, set 948, and adhesive padinto the pinched region of the skin. That is, upon release of thearticulated pin 936 from the first chamber 932, the inserter rod 940 isfree to travel downward as urged by the trapped firing spring 946. Indoing so, the inserter rod 940, including its planar end 944 and needle942 travel downward through the second chamber 934, urging the set 948downward with it. At or before reaching the travel limit of the inserterrod 940, the set 948 is positioned, and the device 925 can be removed asshown in FIG. 17d , thereby leaving the set 948 at the desired insertionsite.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to provide a simple but effective folding/retractable inserteras desired by a user. As shown by way of example, a“folding/retractable” inserter device 1000 is shown in FIGS. 18a-18e .As shown in FIGS. 18a-18e , an exemplary set can be packaged with ahinged, vertical protruding handle 1002 which improves the ability ofthe user to place it and insert it as shown in FIGS. 18b-18c , but whichcan be folded out of the way as shown in FIGS. 18a and 18d . To do so,the inserter 1004 can be constructed having a hinge, pivot pin or pivotpoint, or other flexible-type element 1006 which allows the handle toextend from the set 1008 at a number of angles, especially when the set1008 is adhered to a skin surface.

As shown the cross-sectional views of FIGS. 18b-18d , thefolding/retractable inserter 1000 can comprise the handle 1002 in whicha chamber 1010 is provided to contain an insertion needle 1012 andretraction spring 1014. The handle 1002 further comprises at least oneopening 1016 through which a user-accessible button 1018 can extend. Asshown in FIG. 18b , the opening 1016 and user-accessible button 1018restrict travel of an end of the needle 1012 such that the retractionspring 1014 is compressed and held in the state shown in FIG. 18b . Insuch a position, the inserter can be used in a conventional manner. Oncethe set is in place, the user can press the button 1018 such that theneedle 1012 is released and the retraction spring 1014 can retract theneedle 1012 from the set and into a protected and covered positionwithin the chamber 1010 of the handle 1002 as shown in FIG. 18 c.

As more clearly shown in FIG. 18c , the handle 1002, hinge 1006, andchamber 1010 can further comprise an opening 1020 through which theneedle 1012 can be extended and retracted. The opening 1020 is alignedwhen the handle 1002 is in the upright and perpendicular position. Oncethe needle 1012 is retracted into the chamber 1010, the handle 1002 canbe rotated about the hinge 1006 to any number of positions, butpreferably is rotated to a down and substantially parallel position asshown in FIG. 18d . Once in this position, the inserter is left with theset at the site, but maintains a low profile due to the rotation of thehandle 1002. Further, no danger is presented by the needle 1012 of theinserter as it is fully retracted into the chamber 1010 of the handle1002, and is blocked from further escape as the opening 1020 is nowblocked.

As noted above, the device 1000 can include the user-accessible button1018 at any convenient location along the handle 1002, such that thebutton 1018 locks the needle 1012 in an extended position for insertionas shown in FIG. 18b . After insertion, the button 1018 can be activatedor toggled, allowing the internal retraction spring 1014 to retract theneedle 1012 vertically and automatically to a safe position within thechamber 1010 of the handle 1002 as shown in FIG. 18c . With the needle1012 fully retracted into the handle body, the handle can be folded downby way of the hinge 1006 as shown in FIG. 18d . Such a hinge 1006 canfurther comprise a detented hinge to assist in maintaining the folded orupright position of the handle 1002 as shown in FIG. 18e , and to ensurethat in the folded position, the sharp component is completelyinaccessible and the device assumes and maintains a low profile. To doso, a number of detents 1022 can be provided to gently secure the handle1002 in either the up or down positions.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to provide a simple but effective connection method between thetube connection and set in some manner as desired by a user. As shown byway of example, a “squeeze-type” connection device 1100 is shown inFIGS. 19a-19c . As shown in FIGS. 19a-19c , a connection method isprovided as a squeeze latch 1100 having one or more hinged and rotatablepush buttons within the device that when pressed, release a shoulder,notch or other element of the set.

For example, as shown in FIG. 19a , inside the body of the set 1104, twopush button latches 1102 are provided comprising rotatable L shapedelements, with pivot points 1108 located as shown in FIGS. 19a and 19c ,and which can be used to secure the tube connection 1106 with the set1104. The latches 1102 can be urged into the securing position of FIG.19a using springs, material resilience or other means (not shown).Squeezing the exposed portions of the two latches 1102 toward the centerof the device 1100 causes the internal arms of the latches 1102 to swingfree of the connection with the set 1104 and release it as shown in FIG.19c . Once released, the tube connection 1106 and latches 1102 can belifted from the set 1104. In a similar manner, squeezing the exposedportions of the two latches 1102 toward the center of the device 1100can be used to place the tube connection 1106 back on the set 1104.Further, such a latching embodiment allows the tube connection 1106 torotate about the set 1104 prior to, during and after assembly.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to provide a connection tool and a set configured for use withsuch a connection tool in some manner as desired by a user. As shown byway of example, a connection tool 1154, tubing connection 1152, and set1158 are shown in FIGS. 20a-20d . That is, the device of FIGS. 20a-20dillustrate an exemplary embodiment of a tool removable connection. Sinceuser accessible connection mechanisms can be bulky or inadvertentlyactuated, a compromise can be to provide a release mechanism, but torequire the use of a removal tool to trigger it as shown in FIG. 20 a.

As shown in FIGS. 20a-20c , the tubing connection 1152 residing on topof the set 1158 will have a low profile, and the housing of the tubingconnection 1152 comprises one or more small access openings 1162 asshown. While these openings 1162 are small enough to resist inadvertentdisconnection, they permit insertion of specialized features on theexternal connection tool 1154, which actuates the hinged and rotatablelatches 1156 positioned inside the tubing connection 1152 to release itas shown in the cross-sectional views of FIGS. 20b -20 d.

Specifically, the low profile tube connection 1152 is secured to the set1158 using the hinged and rotatable latches 1156 positioned inside thetubing connection 1152. The tube connection 1152 comprises one or morerotatable brackets 1156 which are configured to rotate about pins 1170.Each of the rotatable latches comprises a shoulder 1172 configured tocapture and securely hold a similar shoulder 1174 provided upon the set1158. Accordingly, in an assembled positions as shown in FIG. 20b , thebrackets 1156 are rotated into a position that secures the set 1158 Thatis, when the connection tool 1154 is not assembled with the low profiletube connection 1152 and set 1158, the hinged and rotatable latches 1156are in upright and secure positions as shown in FIG. 20b . Any number ofmeans can be used to maintain the latches 1156 in such an uprightposition such as springs, material elasticity, and/or contact with theskin surface. While in this position, the latches 1156 serve to captureand secure one or more of the shoulders 1174 of the set 1158.

The connection tool 1154 comprises a substantially cylindrical bodyhaving one or more projections or pins 1160 extending from a lowersurface. The lower surface can be contoured to more closely match theupper surface of the tube connection 1152. Further, the number andarrangement of pins 1160 and/or openings 1162 can be provided based uponthe set such that a particular connection tool can be used with only oneor more sets, or a universal tool can be provided to work with all sets.The tool 1154 can be made of any lightweight, strong material such asplastic or metal, and the pins 1160 can be constructed of similarmaterials to simplify manufacture.

When the connection tool 1154 is pressed against an upper surface of thelow profile tube connection 1152, one or more of the pins 1160 extendingfrom the tool 1154 enter the connection 1152 through one or more of theopenings 1162 and contact the latches 1156. A notch 1164 can be providedin the tool 1154 to allow clearance for the tube 1166, and the tool canfurther comprise a contour 1168 and/or other surface or grippingfeatures. Once engaged, the pins 1160 of the tool 1154 press the latches1156 downward, from the upright and secured positions thereby releasingthe set 1158 as shown in FIG. 20c . After the connection 1152 isreleased from the set 1158, the tool 1154 and tube connection 1152 canbe lifted free of the set 1158 as shown in FIG. 20 d.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements 1200 to manage the tubing of the device in some manner asdesired by a user. As shown by way of example, tube management elements1204 and 1206 are shown in FIGS. 21a-21c . As shown in FIGS. 21a-21b ,one or more loop control elements 1204 and 1206 can be provided tomanage a length of tubing 1202 as desired by the user. Specifically,such tubing management can comprise one or more tubing pull ties 1204and 1206. The two ties 1204 and 1206 can be constructed having integralpull tabs 1210 and 1212, respectively, and can be installed on a loop1208 of tubing 1202 as shown. Pulling on the pump and set ends of thetubing 1202 causes additional slack of the loop 1208 to be released, andthe loop of FIG. 21b to contract as shown in FIG. 21a . Pulling outwardon the pull tabs 1210 and 1212 can then be used to cause the loop 1208to expand, and to reduce slack in the tubing as shown in FIG. 21 b.

As shown in FIG. 21c , one or more of the pull ties can further comprisea clip 1214 to attach the loop of tubing to a user, and which can bepressed in the direction of arrow A to release the clip and loop oftubing from a user's belt or other clothing.

Further, one or more of the exemplary embodiments of the presentinvention described herein can be further provided with additionalfeatures or elements to manage tubing connections of the device in somemanner as desired by a user. As shown by way of example, a “breakaway”coupling and/or connecting engagement between tubes 1226 and 1240 isshown in FIGS. 22a-22c . An advantage of the exemplary embodimentsillustrated in FIGS. 22a-22c is the provision of a secure, leak-freeconnection, that is easily assembled with a push connection action bythe user, and which can disengage automatically when tubing interferenceoccurs, without creating great degrees of tension. That is, theexemplary embodiments illustrated in FIGS. 22a-22c preferably allowdisengagement with minimal “pulling” of opposite tube ends such that theset or pump is not pulled free of the user.

Each exemplary embodiment illustrated in FIGS. 22a-22c preferablyoperates as a push connection. The tubing pieces can have male andfemale ends in which a selected feature provides the desired degree ofengagement. As shown in FIG. 22a , the male end 1228 of tube 1226 canhave a tapered shape, with a diameter and surface characteristics toserve as an in-line, sealable, press-fit with the female end 1234 oftube 1240. In FIG. 22b , the male end 1230 can include one or moreprojecting detents 1242 to provide a snap-fit with similar recesseddetents provided in the female end 1236. In yet another exemplaryembodiment, the male and female ends 1232 and 1238 can further includemagnets 1244, arranged to provide a magnetic attraction between tubes(i.e., north/south magnetic arrangements). In yet other embodiments, oneof the magnets can be replaced with a metal element (not shown) whichresults in a substantially similar attraction with the remaining magnet.

In each embodiment, the coupling and/or connecting engagement betweentubes allows for easy disconnect and/or safety breakaway in the event ofan accidental snag of the tubing. Further, any one of the exemplaryembodiments can be further configured to provide an audible indicationof disconnections, such as a “pop” sound or other alert. Although FIGS.22a-22c show coupling and/or connecting engagements between tubes 1226and 1240, in yet other embodiments of the present invention, thefeatures can be used for connections between tube and set, tube andreservoir, and tube and pump.

Still further, one or more of the exemplary embodiments of the presentinvention described herein can be further provided with other additionalfeatures or elements to manage the tubing of the device in some manneras desired by a user. As shown by way of example, a tube managementelement 1250 is shown in FIGS. 23a-23b . As shown in FIGS. 23a-23b , anelastic accordion element 1254 is provided to manage a length of tubing1252 as desired by the user. The length of the tubing 1252 can becontrolled by a back-and-forth looped portion 1256 of the tubing 1252,wrapped in the elastic binding 1254, as shown. The elastic binding 1254can be provided with one or more stitched or otherwise created seams1258, to hold and/or direct an entering and exiting segment of tubing tomaintain proper operation of the elastic binding during operation. Thiselastic array of tubing can be expanded and contracted as necessary toallow for the ideal management of the tubing.

Still further, one or more of the exemplary embodiments of the presentinvention described herein can be further provided with additionalfeatures or elements to minimize the tubing of the device in some manneras desired by a user. Great lengths of tubing can often result in anumber of undesirable problems. Accordingly, where it is possible to doso, an exemplary embodiment of the present invention provides a system1275 which can be safely implemented using a short tube 1278 as shown inFIGS. 24a -24 c.

The short tube 1278 provided between the set 1276 and the pump 1280 canbe minimal in length, including no slack that may pose a danger oftangling or fouling. The short tube 1278 can also be short enough toallow for disconnection at the pump 1280, such as through any of thedisconnecting means described above, leaving the short length of tubingstill attached to the site. In an exemplary embodiment of the presentinvention, the short tube 1278 can be between 2 and 12 inches in length,and preferably between 3 and 9 inches in length and more preferablybetween 4 and 6 inches in length. The connection 1282 can be aquick-disconnect type, and can be configured to be released by pressingone or more buttons 1284 of the pump 1280 as indicated by the arrows A.

Still further, one or more of the exemplary embodiments of the presentinvention described herein can be further provided with additionalfeatures or elements 1285 to secure, contain, and/or conceal the tubingof the device in some manner as desired by a user. As shown by way ofexample, a tube containment pouch 1288 is shown in FIG. 25a . The kitcan include the pouch 1288 that permits excess tubing 1290 to be bundledup and stowed in such a way as to allow only the required length 1286 tobe freed for use. The pouch 1288 can be constructed in a mannersubstantially similar to that of fabric bag and having a Velcroenclosure, but is not limited thereto. For example, another exemplaryembodiment is shown in FIG. 25b in which a flexible part 1292 can beprovided that permits the tubing 1286 to be easily inserted and storedout of the way. The flexible part 1292 can be constructed of anysuitable material, such as rubber, and can be provided with a number ofslotted openings 1294 and 1296, with varying slot 1298 dimensions tofacilitate both tubing sizes, and ease of tubing insertion, as desiredby the user. The part 1292 can be provided as a half-sphere to maximizeboth tube containment spacing while maintaining a manageable shapeconfiguration. The pouch 1288 or containment part 1292 can be discardedwith the tube.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to conceal, decorate, or alter the appearance of the device insome manner as desired by a user. As shown by way of example, anassembled device 1300 of FIG. 26a illustrates a number of suchadditional features or elements to conceal, decorate, or alter theappearance of the device. In the exemplary embodiment shown, theadditional elements are not provided to conceal the device but rather,decorate or alter the appearance in a desired manner. Specifically,instead of providing means to conceal the set 1302 and tube 1304, theinserted set is decorated or ornamented with customizable additionalparts 1306 and 1308. For example, as shown in the exploded view of FIGS.26b and 26c , the set can be provided with an image element 1306 thatcan be secured to the set 1302 either with a snap fit or otherfriction-type, adhesive-type, or other attachment, or can be trappedagainst the set 1302 by a cover piece 1308. In such a manner, the set1302 can be personalized with the image element 1306 trapped, protected,and/or further customized by the clear, snap-on cover piece 1308.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements to simplify gripping and user positioning of the inserter. Suchan exemplary feature is shown in element 1325 of FIGS. 27a-27b . In theexemplary embodiment shown in FIGS. 27a-27b , an inserter 1326 can beprovided with one or more finger loops for use in the placement of thedevice. In the embodiment shown, the finger loops 1328 allow fortwo-finger placement as illustrated in FIG. 27b . The set can be placedusing such an insertion device 1326 with the two finger loops 1328 asshown, which enhance stability and precision of set placement. Althoughtwo completely encircled finger loops are shown, embodiments of thepresent invention are not limited thereto. In yet other embodiments ofthe present invention, a combination of complete and partial loops(i.e., spurs) can be used.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements for the use of site preparation. Such an exemplary feature isshown in element 1350 of FIG. 28. In the exemplary embodiment shown inFIG. 28, an inserter 1352, such as those described above, can beprovided with a spray mechanism 1354 at an upper most point of theinserter which contains a small amount of site preparation contents. Thespray mechanism can be provided with a finger actuator 1356 that can beused by a user to spray the contents upon a site for site preparation.The contents can comprise, but are not limited to, anesthetic,disinfectant, or a combination of both, and can be applied by sprayingfrom a small reservoir (not shown) and outlet incorporated into theinsertion device.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements for the provision and use of an advanced design infusion set.Such an exemplary advanced design infusion set is shown comprising, inpart, elements 1360 of FIGS. 29a-29c . FIG. 29a is a cross-sectionalview of the hub 1362 of the infusion set, in which the hub 1362 providesan annular fluid reservoir and/or fluid path 1364 which cansignificantly minimize the penetration distance of the tubeset connectorinto the hub while maintaining a sufficiently large tubeset connectorgeometry.

The infusion set, as with others described herein, can be provided forthe continuous subcutaneous infusion of insulin or other medications.The infusion set comprises the hub 1362, which is affixed to a skinsurface 1366 of a body with adhesive as described above, and furthercomprises a tubeset 1368 which creates and maintains a fluid path froman infusion pump and/or reservoir (not shown) and the hub 1362. Theexemplary hub 1362 illustrated in FIG. 29a comprises a polyurethanecatheter 1370 extending from the hub 1362 through the skin surface 1366and into the subcutaneous tissue. The hub can be constructed ofmaterials having a viscoelastic property, and which are flexible, suchas thermoplastic elastomer (TPE), thermoplastic urethane (TPU),silicone, or similar materials. As with many of the exemplaryembodiments of the present invention described herein, the hub 1362 isconfigured to have a low profile to minimize interference, such ascatching on clothing or fixed objects such as doorframes or cabinets.The hub 1362 can be further configured as described herein to have oneor more clear or transparent features to enable site visualization andinspection.

The central portion of the hub 1362 can comprise the annular space 1364in fluid communication with the catheter 1370 lumen. The annular space1364 can be configured in any number of ways to minimize deadspacewithin the hub 1362, yet allow insertion needle penetration andsubsequent closure of the penetration site, and provide tubeset needlepenetration from any number of rotational positions of the tubeset asdescribed in greater detail below. An advantage of providing such a hub1362 with an annular interior is the ability to minimize the penetrationdistance of the tubeset connector into the hub while maintaining asufficiently large tubeset connector geometry. Yet another advantage isthe ability to minimize the volume of insulin or other medication leftin the hub fluid cavity.

In an exemplary embodiment of the present invention, the annular space1364 comprises a shallow or narrow central portion such that an uppersurface, to be penetrated by the insertion needle 1372, is close to thecatheter 1370 lumen. A peripheral area of the annular space 1364 isprovided with a wider space extending along the inner wall of the hub1362. In doing so, the engagement with the tubeset connector issimplified, and further allows tubeset engagement at any rotationalposition.

The hub 1362 can be inserted through the skin surface 1366 and into thesubcutaneous tissue via the insertion needle 1372 that extends throughthe top surface of the hub 1362, through the annular space 1364 andthrough the catheter 1370 lumen. After insertion into the skin, theinsertion needle 1372 (and needle hub) can be withdrawn and theresulting hole in the hub top surface can be configured to self-seal dueto the elastomeric qualities of the hub materials after setting. Thatis, the annular fluid space 1364 can reseal any insertion openingsgenerated by the insertion needle 1372, and allow penetration by atubeset connector needle as described in greater detail below.

The exemplary tubeset connector 1368 also comprises, at least in part,the same or similar construction materials. The tubeset connector 1368can be constructed of a viscoelastic material and utilizes the materialcharacteristics to create and maintain a connection with the hub 1362.The tubeset connector 1368 comprises an elasticized ring 1374 with aninner diameter, shape and profile that matches a central, recessed orgrooved portion 1375 of the hub 1362, and a tube 1378. As shown in FIG.29a , the central portion 1375 of the hub 1362 can comprise a groove orcontour for guiding, receiving and securing the elasticized ring 1374.To do so, the elasticized ring 1374 can be gently expanded by the userand placed into the central portion 1375 such that when released, theelasticized ring 1374 relaxes into a size and shape that secures thetubeset 1368 with the hub 1362.

At one location of the elasticized ring 1374 inner surface, the tubesetneedle or spike 1376 is provided and protrudes radially inward.Accordingly, when the elasticized ring 1374 is placed onto the hub 1362as described above, the tubeset needle 1376 punctures the wall of thecentral portion 1375 of the hub 1362 and thereby creates a fluid pathfrom the tubeset 1368 to the annular cavity 1364 of the hub 1362. Theelastomeric qualities of the hub materials allow the needle punctures toself seal upon needle removal. In doing so, the tubeset 1368, using theelasticized ring 1374 connector, can be affixed to the hub 1362 in anyrotational alignment position. Further, the elasticity of the materialsallows the elasticized ring 1374 to be removed from one position andrepositioned elsewhere as desired, and each unused insertion site issealed.

One or more of the exemplary embodiments of the present inventiondescribed herein can be further provided with additional features orelements for the provision and use of an advanced design catheter. Suchan exemplary advanced design catheter is shown in element 1380 of FIG.30. FIG. 30 is a cross-sectional view of a catheter including one ormore cross-drilled holes and a splined lumen in accordance with anexemplary embodiment of the present invention. In the exemplaryembodiment shown, the catheter 1380 can be constructed of a bodytemperature softening polyurethane or similar material, such as aproprietary Vialon material, and include one or more features includinga splined lumen and holes or openings along a body length, includingcross-drilled holes. For example, the catheter can comprise a splinedlumen 1382 to prevent kinking, and flow occlusion in the event of akinked catheter or otherwise. The splines 1382 can be provided asmembers raised from the inner wall of the catheter 1380 and/or providedas members depressed into the inner wall of the catheter 1380, to beuniformly spaced and to extend along the axis of the catheter. Forexample, the splines can comprise a linear axis to run parallel to theaxis of the catheter and/or can comprise a helical axis, eitherright-handed or left-handed, to form a helix curve about the axis of thecatheter. Although four equally-spaced splines 1382 are shown in FIG.30, embodiments of the present invention are not limited thereto.

Additionally, the catheter 1380 can comprise on or more holes oropenings, such as the cross-drilled holes 1384 shown in FIG. 30. Asshown, the holes can be aligned as resulting from drilling, punching orotherwise molding through holes at points along the body of thecatheter. Any number of openings or holes can be provided, eitheruniformly over the body of the catheter or in arrangements of varyingconcentrations, and can comprise openings of approximately ¼ of theinner diameter of the catheter, but each are not limited thereto. Theholes can be provided to facilitate infusion of the contents, such asinsulin or other medication, in the subcutaneous tissue adjacent to thecatheter in addition to, or instead of, the tissue at the catheter tip.

To this point, a number advanced, improved, and novel new components,elements and packaging of current and future insulin infusion sets, havebeen described. Accordingly, a number of advantages and improvementsover existing systems and methods include the feature of providing theset and some or all of its peripherals in one package. Many of theproposed insertion devices both insert and retract the needle and thencover it for safe disposal. The described fluid connections from thepump to the site require no moving parts and allow for easydisconnection. Other features allow the user to inspect the insertionarea for irritation after insertion via a magnifying window in the site,and tube management is obtained by using a tube reel or other embodimentthat allows the user to manage excessive tube length conveniently andadjust length as needed. The described insulin reservoir and tube arepre-filled and do not require priming by the user, and the concealmentand decorative patches allow the user to cover and protect the siteeither inconspicuously or with distinction. The described site targetingring allows the user to more accurately locate the site prior toinsertion, and the disposable wipes and sprays combine disinfectant andanesthetic application steps into one step.

Although only a few exemplary embodiments of the present invention havebeen described in detail above, those skilled in the art will readilyappreciate that many modifications are possible in the exemplaryembodiments without materially departing from the novel teachings andadvantages of this invention. Accordingly, all such modifications areintended to be included within the scope of this invention.

The invention claimed is:
 1. A sealed packaged infusion set, comprising:a sealable tray; a cover; a set, comprising a skin contacting surfaceand a catheter extending therefrom; an inserter, configured to securesaid set for placement at an insertion site; a medicament supplycontaining a medicament, for providing said medicament to said set; atube, comprising at least one length of tubing for communicating saidmedicament from said medicament supply to said set; and a placementassistance element configured for, subsequent to said placementassistance element being adhered to a patient's skin, initially engagingwith and guiding said inserter and guiding said set to the insertionsite, said placement assistance element being removable from saidpatient's skin while said set is maintained at said insertion site; andwherein said cover seals said set, inserter, medicament supply, tube,and placement assistance element in said sealable tray.
 2. The packagedinfusion set of claim 1, wherein said sealable tray comprises: aplurality of recessed openings configured to orient and secure saidinserter, said set, said medicament supply, and said placementassistance element; and a set package comprising a second plurality ofrecessed openings configured to orient and secure said set, wherein saidset package is covered with a pierceable cover configured to releasesaid set upon being pierced by said inserter; wherein said covercomprises at least one of a clear cover and a labeled cover configuredto identify said inserter, said set, said tube, said medicament supply,said placement assistance element, and a site preparation element ofsaid sealable tray.
 3. The packaged infusion set of claim 1, whereinsaid inserter comprises: a main housing; an inserter rod, slidablydisposed within said main housing; and a push-button, slidably extendingfrom a first end of said main housing and configured to release saidinserter rod to slide toward a second end of said main housing; saidmain housing comprising a substantially open second end configured toslidably receive said set, and to release said set at the insertion siteas directed by said inserter rod.
 4. The packaged infusion set of claim1, wherein said inserter comprises: a main housing; an inserter rod,slidably disposed within said main housing; and a push-button, rotatablydisposed at a side of said main housing and configured to release saidinserter rod to slide toward an end of said main housing; said mainhousing comprising a substantially open end configured to slidablyreceive said set, and to release said set at the insertion site asdirected by said inserter rod.
 5. The packaged infusion set of claim 1,wherein said inserter comprises: a main housing, comprising at least oneuser-deflectable body portion; and an inserter rod, slidably disposedwithin said main housing, wherein said user-deflectable body portion isconfigured to release said inserter rod to slide toward an end of saidmain housing; said main housing comprising a substantially open endconfigured to slidably receive said set, and to release said set at theinsertion site as directed by said inserter rod.
 6. The packagedinfusion set of claim 1, wherein said inserter comprises: a mainhousing; an inserter rod, slidably disposed within said main housing;and a lower housing, slidably disposed within an open end of said mainhousing and configured to contact the patient's skin at the insertionsite, and further configured to release said inserter rod to slidetoward an end of said lower housing when said lower housing contactssaid skin surface; said lower housing comprising a substantially openend configured to slidably receive said set, and to release said set atthe insertion site as directed by said inserter rod.
 7. The packagedinfusion set of claim 1, wherein said inserter comprises: a mainhousing, comprising a first leg and a second leg opposite of said firstleg, said first leg and said second leg configured to pivot about amidpoint, wherein at a first position, said first leg and said secondleg are configured to secure an inserter rod within said main housing,and at a second position, said first leg and said second leg areconfigured to release said inserter rod within said main housing; andsaid inserter rod, slidably disposed within said main housing; said mainhousing comprising a substantially open end configured to slidablyreceive said set, and to release said set at the insertion site asdirected by said inserter rod.
 8. The packaged infusion set of claim 7,wherein at said second position, said first leg and said second leg areconfigured to manipulate said insertion site within said substantiallyopen end of said main housing.
 9. The packaged infusion set of claim 1,wherein said inserter comprises: a main housing, comprising at least onepushbutton extending therefrom; and an inserter rod, slidably disposedwithin said main housing, wherein said inserter rod is captured in anextended position by said pushbutton of said main housing, and isconfigured to slidably retract within said main housing upon activationof said pushbutton; wherein said main housing is rotatably secured tosaid set and is configured to rotate from a first position to a secondposition upon retraction of said inserter rod.
 10. The packaged infusionset of claim 1, wherein said inserter comprises: a main housing,comprising at least one pushbutton extending therefrom, wherein saidmain housing is substantially open at a first end for slidably receivingsaid set; and wherein said pushbutton is biased toward a first positionto secure said set within said main housing and is configured to rotateto a second position to release said set from within said main housing.11. The packaged infusion set of claim 1, wherein said set comprises: aplurality of concentric adhesive areas, wherein a first concentricadhesive area is configured to provide a first degree of adhesion, and asecond concentric adhesive area is configured to provide a second degreeof adhesion, wherein said first degree of adhesion is greater that saidsecond degree of adhesion; and a plurality of covers for said pluralityof concentric adhesive areas, respectively.
 12. The packaged infusionset of claim 1, wherein said set comprises at least one constructionmaterial configured to permit visibility between an upper surface and alower surface of said set at or near the insertion site.
 13. Thepackaged infusion set of claim 1, wherein said set comprises at leastone cover for an upper surface of said set configured to substantiallyconceal said set or decorate said set.
 14. The packaged infusion set ofclaim 1, wherein said tube and tube management devices comprise at leastone of: a tube reel configured to store said tube in a substantiallycircular manner; at least a first clip and a second clip configured tostore said tube in a substantially circular manner; an elastic bindingconfigured to store said tube in a substantially accordion manner; awrapping binding configured to store said tube in a substantiallybundled manner; and a flexible cup-shaped element configured to storesaid tube; wherein said tube can be provided having a targeted length tominimize excess tubing for storage.
 15. The packaged infusion set ofclaim 1, wherein said tube and tube management devices comprises: aflexible ring, configured to expand to a first diameter to allowplacement over said set, and contract to a second diameter to securelycircumscribe an outer diameter of said set; a tubing length secured tosaid flexible ring; and a fitting, disposed at an end of said tubinglength and extending into said flexible ring, said fitting configured tosealably mate with an opening of said set to permit communication of amedicament between said set and said tubing length.
 16. The packagedinfusion set of claim 15, wherein said set comprises: a hub, constructedof a viscoelastic material, wherein said fitting comprises a cannulaconfigured to sealably pierce said hub.
 17. The packaged infusion set ofclaim 16, wherein said viscoelastic material comprises at least one of athermoplastic elastomer (TPE), thermoplastic urethane (TPU), orsilicone.
 18. The packaged infusion set of claim 1, wherein said tubeand tube management devices comprise at least one tubing connectionhaving at least one of a tapered tubing end, a tubing end having one ormore detents, and a magnetically attractable tubing end.
 19. Thepackaged infusion set of claim 18, wherein said at least one tubingconnection is configured to generate an audible indication whendisconnected.
 20. The packaged infusion set of claim 1, wherein saidmedicament supply comprises at least one medicament container, a tubingsegment and a tubing connection, wherein said medicament container isconfigured to indicate a content quantity therein.
 21. The packagedinfusion set of claim 1, wherein said catheter comprises a splined lumenand wherein a spline of said splined lumen comprises one of a linearaxis and a helical axis.
 22. The packaged infusion set of claim 1,wherein said catheter comprises at least one hole or opening along abody length.
 23. The packaged infusion set of claim 1, wherein saidcatheter is made of a body temperature softening polyurethane.
 24. Thepackaged infusion set of claim 1, wherein said placement assistanceelement comprises: a placement ring, configured to adhere to saidinsertion site such that said insertion site is centered within anopening of said placement ring, said insertion ring comprising at leastone detent configured to receive a detent of said inserter; and saidinserter, configured to removably mate with said placement ring andplace said set at said insertion site.
 25. The packaged infusion set ofclaim 1, wherein said inserter comprises at least one finger loop. 26.The packaged infusion set of claim 1, further comprising a connectiontool including a body and at least one pin extending from the bodytherefrom, wherein said pin is configured to engage a rotatable latch ofa tube connection and in response, release said tube connection fromsaid set.
 27. The packaged infusion set of claim 1, wherein saidinserter further comprises at least one hinged member adjacent to aninsertion needle, wherein said hinged member is configured to rotatebetween a first position configured to allow insertion of said set, anda second position to substantially cover said insertion needle afterinsertion of said set.
 28. The packaged infusion set of claim 1, whereinsaid placement assistance element has an opening through which saidinserter inserts said set to said insertion site.
 29. The packagedinfusion set of claim 1, wherein said inserter comprises: a mainhousing, comprising a first leg and a second leg opposite of said firstleg, said first leg and said second leg configured to pivot about acommon axis of rotation.
 30. A packaged infusion set comprising: asealable tray for receiving and containing elements of an infusion set;an inserter, configured to secure a set for placement at an insertionsite; said set, comprising a skin contacting surface and a catheterextending therefrom; and a tube, comprising at least one length oftubing for communicating a medicament from a medicament supply to saidset; and a placement assistance element separate from the inserter andhaving an opening and an adhesive for adhering said placement assistanceelement to a patient's skin, and being configured to: subsequent toadhering said placement assistance element to said patient's skin,initially contact and guide said inserter and guide said set throughsaid opening to said insertion site; and be removable from saidpatient's skin while said set is maintained at said insertion site. 31.The packaged infusion set of claim 30, wherein said inserter comprises:a main housing; an inserter rod, slidably disposed within said mainhousing; and a push-button, rotatably disposed at a side of said mainhousing and configured to release said inserter rod to slide toward anend of said main housing; said main housing comprising a substantiallyopen end configured to slidably receive said set, and to release saidset at the insertion site as directed by said inserter rod.
 32. Thepackaged infusion set of claim 30, wherein said inserter comprises: amain housing, comprising at least one pushbutton extending therefrom;and an inserter rod, slidably disposed within said main housing, whereinsaid inserter rod is captured in an extended position by said pushbuttonof said main housing, and is configured to slidably retract within saidmain housing upon activation of said push button; wherein said mainhousing is rotatably secured to said set and is configured to rotatefrom a first position to a second position upon retraction of saidinserter rod.
 33. The packaged infusion set of claim 30, furthercomprising a connection tool including one or more projections or pinsextending from a lower surface thereof; and a tubing connectionincluding a housing with one or more openings, wherein the tubingconnection is disposed on the set.
 34. The packaged infusion set ofclaim 33, wherein the one or more projections or pins of the connectiontool are configured to engage the one or more openings of the tubingconnection to release the tubing connection from the set.
 35. Thepackaged infusion set of claim 30, wherein said placement assistanceelement includes an inserter orienting feature and said inserterincludes a placement assistance element orienting feature, said inserterorienting feature and said placement assistance element orientingfeature interacting to orient the inserter relative to the placementassistance element.
 36. A packaged infusion set comprising: a sealabletray; a set, comprising a skin contacting surface and a catheterextending therefrom; an inserter, configured to secure said set forplacement at an insertion site; a tube, comprising at least one lengthof tubing for communicating a medicament from a medicament supply tosaid set; and a placement assistance element, configured to: be adheredat said insertion site; subsequent to adhering said placement assistanceelement at said insertion site, initially engage with and guide saidinserter and guide said set to said insertion site; and be separablefrom said inserter and removable from said insertion site while said setis maintained at said insertion site.
 37. The packaged infusion set ofclaim 36, wherein said inserter comprises: a main housing, comprising atleast one pushbutton extending therefrom; and an inserter rod, slidablydisposed within said main housing, wherein said inserter rod is capturedin an extended position by said pushbutton of said main housing, and isconfigured to slidably retract within said main housing upon activationof said pushbutton; wherein said main housing is rotatably secured tosaid set and is configured to rotate from a first position to a secondposition upon retraction of said inserter rod.
 38. The packaged infusionset of claim 36, further comprising a connection tool including one ormore projections or pins extending from a lower surface thereof; and atubing connection including a housing with one or more openings, whereinthe tubing connection is disposed on the set.
 39. The packaged infusionset of claim 38, wherein the one or more projections or pins of theconnection tool are configured to engage the one or more openings of thetubing connection to release the tubing connection from the set.
 40. Thepackaged infusion set of claim 36, wherein said placement assistanceelement includes an inserter orienting feature and said inserterincludes a placement assistance element orienting feature, said inserterorienting feature and said placement assistance element orientingfeature interacting to orient the inserter relative to the placementassistance element.